Palliative CareNCT03874195
Palliative Care For Me (PCforMe)
A study testing Access to PCforMe for review and Access to three nationally-recognized Palliative Care websites for review in people with Palliative Care, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test the usability of PCforMe, a web-based preparation and engagement tool about palliative care, during a pre-visit pilot trial in outpatient palliative care at the Duke Cancer Institute Palliative Care Clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Access to PCforMe for review and Access to three nationally-recognized Palliative Care websites for review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2017to 26 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential participants will be identified by reviewing clinic appointment listings in EPIC (e.g., diagnosis, date of diagnosis, date of clinic appointment, physician), and deemed eligible by the RA by meeting the following criteria:
- Age >18
- capacity to give consent
- has a scheduled outpatient visit (initial consult) with a palliative care provider
- ability to speak and understand English
Who cannot join
- Not meeting the inclusion requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Cancer Center
Durham, North Carolina, 27705
About this study
Official title: Usability Testing of a Web-based Tool to Prepare Patients for Palliative Care
The purpose of this study is to test the usability of PCforMe, a web-based preparation and engagement tool about palliative care, during a pre-visit pilot trial in outpatient palliative care at the Duke Cancer Institute Palliative Care Clinic.
Read the detailed description
The Investigator will 1:1 randomize patients to an Active Control arm or Intervention arm. Both arms will receive a tablet computer (iPad or Galaxy Tab based on preference) connected to the internet with disposable headphones to use for up to 30 minutes. Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative_care). Intervention Arm subjects will receive access to PCforMe.
PCforMe is an online, web-based, interactive tool to prepare patients for a clinical palliative care encounter. PCforMe is accessible through www.pcforme.org. It does not collect any patient information, including identifiers (e.g. name, email address, disease, location) or health information (e.g. disease, symptom severity or location). The system uses a combination of animated videos and user-answered questions to generate a "Palliative Care Passport", which is a summary of information entered into the system. Research staff will print out the Passport for patients and hand it to them prior to the appointment.
Queries for users include standard-of-care questions asked by palliative care clinicians, including areas that patients want to more learn about. No diagnoses, medication advice, or clinical assessments are made or given.
- Conditions
- Palliative Care
- Being tested
- Access to PCforMe for review, Access to three nationally-recognized Palliative Care websites for review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to PCforMe for reviewBehavioural
Also called Knowledge of Palliative Care, Prepartion for Palliative Care appointment, Confidence in Palliative Care discussion with provider
Intervention Arm subjects will receive access to PCforMe.
Access to three nationally-recognized Palliative Care websites for reviewBehavioural
Also called Knowledge of Palliative Care, Prepartion for Palliative Care appointment, Confidence in Palliative Care discussion with provider
Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative care). Receives: Behavioral: Access to three nationally-recognized Palliative Care websites for review |
| Intervention | Experimental | Intervention Arm subjects will receive access to PCforMe. Receives: Behavioral: Access to PCforMe for review |
What is being measured
The primary outcome is the main question the study is designed to answer.
System usability as measured by the system usability scale
To determine usability, the System Usability Scale will be administered to each participate. As described by usability.gov: "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret the participant's results involves "normalizing" the scores to produce a percentile ranking." The original scale is a 10-item, 5-point Likert scale.
Measured: 1 hour
Secondary outcomes (3)
Change in Palliative Care knowledge
Regarding the change in knowledge outcome, Two-side P value of <0.05 will infer significance. The Palliative Care Knowledge instrument is a 4-item, multiple choice assessment of palliative care knowledge. Only one answer is correct. A change in knowledge of Palliative Care will be determined based on the answer provided in the follow-up assessment
Measured: Baseline, up to 1 hour
Change in Perceived Efficacy for the Patient-Physician Interaction (PEPPI)
Change in PEPPI will be determined using 5-point Likert response - 1 being Not at all Confident and 5 being Very Confident
Measured: Baseline, up to 1 hour
Change in single-item Prepared item
"I feel prepared for my palliative care appointment" (5-point Likert response - Strongly Disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree)
Measured: Baseline, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start11 Jan 2017
- Primary completion26 Feb 2018
- Study completion26 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Investigator will 1:1 randomize patients to an Active Control arm or Intervention arm. Both arms will receive a tablet computer (iPad or Galaxy Tab based on preference) connected to the internet with disposable headphones to use for up to 30 minutes. Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative\_care). Intervention Arm subjects will receive access to PCforMe.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arif Kamal, MD, Principal investigator, Duke University Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874195
- Sponsor's protocol ID
- Pro00075906
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Testing of a Web-based Tool to Prepare Patients for Palliative Care
- ClinicalTrials.gov ID
- NCT03874195
- Acronym / sponsor ID
- Pro00075906
- Conditions
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the usability of PCforMe, a web-based preparation and engagement tool about palliative care, during a pre-visit pilot trial in outpatient palliative care at the Duke Cancer Institute Palliative Care Clinic.
Detailed description
The Investigator will 1:1 randomize patients to an Active Control arm or Intervention arm. Both arms will receive a tablet computer (iPad or Galaxy Tab based on preference) connected to the internet with disposable headphones to use for up to 30 minutes. Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative_care). Intervention Arm subjects will receive access to PCforMe.
PCforMe is an online, web-based, interactive tool to prepare patients for a clinical palliative care encounter. PCforMe is accessible through www.pcforme.org. It does not collect any patient information, including identifiers (e.g. name, email address, disease, location) or health information (e.g. disease, symptom severity or location). The system uses a combination of animated videos and user-answered questions to generate a "Palliative Care Passport", which is a summary of information entered into the system. Research staff will print out the Passport for patients and hand it to them prior to the appointment.
Queries for users include standard-of-care questions asked by palliative care clinicians, including areas that patients want to more learn about. No diagnoses, medication advice, or clinical assessments are made or given.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Investigator will 1:1 randomize patients to an Active Control arm or Intervention arm. Both arms will receive a tablet computer (iPad or Galaxy Tab based on preference) connected to the internet with disposable headphones to use for up to 30 minutes. Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative_care). Intervention Arm subjects will receive access to PCforMe.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Access to three nationally-recognized Palliative Care websites for reviewSubjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative care). |
| Intervention | Experimental | Behavioral: Access to PCforMe for reviewIntervention Arm subjects will receive access to PCforMe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Potential participants will be identified by reviewing clinic appointment listings in EPIC (e.g., diagnosis, date of diagnosis, date of clinic appointment, physician), and deemed eligible by the RA by meeting the following criteria:
Key exclusion criteria (1 listed)
- Not meeting the inclusion requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to PCforMe for reviewAlso: Knowledge of Palliative Care, Prepartion for Palliative Care appointment, Confidence in Palliative Care discussion with providerIntervention Arm subjects will receive access to PCforMe. | Behavioural | Intervention |
| Access to three nationally-recognized Palliative Care websites for reviewAlso: Knowledge of Palliative Care, Prepartion for Palliative Care appointment, Confidence in Palliative Care discussion with providerSubjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care | Behavioural | Control |
Primary outcome
System usability as measured by the system usability scale
Time frame: 1 hour
To determine usability, the System Usability Scale will be administered to each participate. As described by usability.gov: "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret the participant's results involves "normalizing" the scores to produce a percentile ranking." The original scale is a 10-item, 5-point Likert scale.
3 secondary outcomes
Change in Palliative Care knowledge
Time frame: Baseline, up to 1 hour
Change in Perceived Efficacy for the Patient-Physician Interaction (PEPPI)
Time frame: Baseline, up to 1 hour
Change in single-item Prepared item
Time frame: Baseline, up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Palliative Care
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Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Intractable Pain, Palliative Care
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Effect of Abdominal Massage Training Provided to Caregivers on Constipation Management
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SPAMLO-3.0 : Having Fun Shedding Light on Darkness, a Playful Approach to Reduce Anxiety in Palliative Care
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Adding Spatially Fractionated Radiation Therapy to Standard Palliative Radiation for Improving Disease-Related Symptoms in Patients With Unresectable Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Kamal, MD principal investigator
Duke University Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to PCforMe for review and Access to three nationally-recognized Palliative Care websites for review in people with Palliative Care, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System usability as measured by the system usability scale (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.